Status:
TERMINATED
The Effects of Lovaza® in Acute Myocardial Infarction
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
GlaxoSmithKline
Albany College of Pharmacy and Health Sciences
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will explore the safety and effectiveness of adding Lovaza® to the therapeutic program utilized internationally for the treatment of individuals with acute coronary syndromes.
Detailed Description
Atherosclerotic cardiovascular disease is the cause for over 19 million deaths in the US annually with coronary artery disease accounting for most of this mortality burden.1 Despite major advances in ...
Eligibility Criteria
Inclusion
- Acute myocardial infarction documented by at least 2 of the following:
- Typical symptoms
- Abnormal levels of cardiac biomarkers (troponin I or T or CK-MB mass) with at least one determination \> 99th percentile or ULN for the laboratory
- ECG findings diagnostic of myocardial infarction based on the American College of Cardiology criteria.
- Status-post urgent or emergent PCI
- Have a Thrombolysis In Myocardial Infarction (TIMI) flow grade = 3 (complete perfusion) post PCI.
- Have the capacity for informed consent (e.g. without significant dementia or sedation from medication)
- Ingested 325 mg of chewed aspirin as part of the acute coronary syndrome treatment protocol.
Exclusion
- No informed consent
- Daily aspirin use prior to index hospitalization
- Known prior myocardial infarction
- Known pregnancy
- Known allergy to fish, fish oil, or aspirin
- Known active internal or non-superficial bleeding, known bleeding disorder, coagulation defect, or thrombocytopenia
- Thrombolysis in the past 12 hours
- Treatment with a IIbIIIa inhibitor during index hospitalization
- Cardiogenic shock or symptomatic hypotension or sitting SBP \< 95 mmHg
- Severe uncontrolled hypertension (≥180/110) or hypertensive retinopathy
- A history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal (not hemorrhoidal) or genitourinary bleeding in the past 6 weeks
- A history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
- A known arteriovenous malformation or aneurysm
- Severe liver insufficiency (ALT ≥ 3 times normal)
- Renal insufficiency requiring dialysis
- A known diagnosis of vasculitis
- Participation in another clinical study
- History of malignancy, except subjects who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
- Oral contraceptive use
- Daily use of NSAIDs
- History of drug or alcohol abuse, or current weekly alcohol consumption \>14 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 shot of alcohol)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01155336
Start Date
June 1 2010
End Date
May 1 2011
Last Update
November 6 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University or Rochester
Rochester, New York, United States, 14642